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Recruiting Observational

Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure

NCT07560982 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-05-08
Last updated
2026-07-06

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

GDMT →Quality of life questionnaire

GDMT: Percentage of patients receiving GDMT in advanced heart failure

Quality of life questionnaire: Absoute Quality of life questionnaire scores (SF 36 questionnaire and EqVAS scale, both validated in Italian language

Study summary

A Prospective Observational, Multi-Center, Real-World Pharmacological Study Evaluating Adherence to Guideline-Directed Medical Therapy Using the Four-Pillar Strategy in Patients with Advanced Heart Failure

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age \> 18 and \< 75 years 2. Heart failure with left ventricular ejection fraction ≤ 35% 3. Persistent symptoms of heart failure, New York Heart Association class III or IV 4. Requirement for high-dose diuretic therapy, specifically Furosemide \> 50 mg/day orally as per routine clinical practice 5. At least one of the following additional indicators of severity or refractoriness: 6. need for progressive escalation of diuretics, 7. intolerance to optimized medical therapy, 8. persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and/or MitraClip 9. Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes Exclusion Criteria: 1. Age ≤ 18 years or ≥ 75 years 2. Left ventricular ejection fraction \> 35% 3. Mild or absent symptoms (New York Heart Association class I-II) 4. Good response to optimized conventional guideline-directed medical therapy 5. Extreme frailty or severe non-reversible disability, or psychiatric or cognitive disorders preventing adherence to follow-up 6. Pregnant or breastfeeding women

Primary outcome measure(s)

  • assess the adherence to guideline-directed medical therapy in patients with advanced heart failure — 3 months, 6 months, 1 year, 2 years, 5 years
    Percentage of patients receiving GDMT in advanced heart failure

Trial sites (2)

FacilityCityRegionStatus
ASST Ospedale Papa Giovanni XXIII Bergamo Italy Not Yet Recruiting
IRCCS Ospedale San Raffaele Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07560982 on ClinicalTrials.gov ↗ ← All trials in Italy